Hepatitis CNCT03603327
Response Guided Treatment With Direct Acting Anti-Viral Medications for Chronic HCV Infection
A study testing Direct acting anti-viral agents in people with Hepatitis C, run by Soroka University Medical Center at 2 sites in Israel.
Trial summary
To evaluate the efficacy and safety of direct acting anti-viral agents (DAA) therapy in chronically infected Hepatitis C Virus (HCV) patients using an individualized response guided therapy (RGT) model. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Direct acting anti-viral agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- 25 Feb 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Clalit insured patients
- Female and male over the age of 18
- Capacity to provide written informed consent
- HCV RNA Viral Load (VL) larger than 105 IU/mL at screening and on at least one other occasion 6 months or more prior to the most recent HCV RNA test result.
- HCV genotypes 1a, 1b, 2, 3 or 4
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- Liver fibrosis stage 0-4 as determined by one of the following methods performed within 2 years prior to the screening visit:
- Fibrotest
- Transient elastography
- Liver biopsy using the METAVIR scoring system.
- Patients must have the following laboratory parameters within 3 months of screening
- ALT and AST ≤ x10 the upper limit of normal (ULN)
- Direct bilirubin ≤ 1.5 the ULN
- Platelet count ≥70,000
- Hemoglobin ≥10 mg/dL
- Albumin ≥3 mg/dL
- INR ≤ 1.5 x ULN
- eGFR ≥ 60 mL/min as calculated by the Cockroft-Gault equation.
- Abdominal ultrasound, C.T or MRI scan showing no evidence of a focal lesion suspicious of hepatocellular carcinoma within 6 months of enrollment.
- A female patient will be eligible to enter the study if it is confirmed that she is:
- Not pregnant or nursing
- Of non-childbearing potential (following hysterectomy, bilateral oophorectomy or post-menopausal)
- Women of childbearing potential- must have a negative urine pregnancy test at baseline and willing to use an accepted mechanical, medical or surgical birth control method from the day of screening until 90 days from the last dose of study drug.
- All male participants in the study must agree to consistently and correctly use a condom, while their female partner agrees to use one of the above-mentioned birth control methods from the day of screening until 90 days after the last dose of study drug.
- Patient must be able to comply with the dosing instructions for the study drug administration and able to complete the study schedule of assessments including all required post-treatment visits.
Who cannot join
- Clinical, serologic or histopathological evidence supporting the presence of chronic liver disease other than HCV (Including but not limited to: HBV, HDV or HIV coinfection, non-alcoholic steatohepatitis, alcoholic liver disease, Wilson's disease, A1AT deficiency and Celiac disease). Workup performed within 6 months of recruitment will be considered sufficient to exclude the above-mentioned conditions (except for A1AT deficiency and Wilson's disease for which exclusion at any time point qualifies).
- Current or past history of any of the following:
- Clinically significant illness (other than HCV) or any other medical disorder that may interfere with patient's assessment, treatment or compliance with the protocol. Examples include congestive heart disease with moderate to severe left ventricular function and chronic obstructive pulmonary disease requiring chronic corticosteroid therapy.
- Clinical evidence of decompensated liver disease (e.g. ascites, bleeding esophageal varices, spontaneous bacterial peritonitis, encephalopathy or hepatorenal syndrome.)
- Child Pugh score higher than 6
- Gastrointestinal disorder or post-operative condition that may interfere with the absorption of the study drug.
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- Solid organ transplantation
- Malignancy within 5 years prior to screening with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer etc.) Patients under the evaluation for possible malignancy are not eligible.
- Any prior treatment with a DAA (protease inhibitors, NS5A inhibitors, NS5B polymerase inhibitors/non-nucleoside polymerase inhibitors)
- Use of anti-viral medications within 30 days of screening.
- Chronic use of systemically administered immunosuppressive/immune- modulating medications
- Clinically relevant substance abuse within 6 months of enrollment. Patient with prior history of drug addiction who are currently maintained on a stable dose of opiate substitutes (naloxone) will be allowed to participate in the study if they can provide documentation of repeated negative toxicology screens from the 6 months prior to screening.
- Participating in clinical trial 30 days before screening.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Efficacy and Safety of Response Guided Treatment With Direct Acting Anti-Viral Medications for Chronic HCV Infection - A Pilot Study
To evaluate the efficacy and safety of direct acting anti-viral agents (DAA) therapy in chronically infected Hepatitis C Virus (HCV) patients using an individualized response guided therapy (RGT) model.
Read the detailed description
Treatment of HCV infection is directed at achieving sustained virological response (SVR), defined as the continued absence of detectable HCV RNA for 12 or more weeks after completion of therapy Given the limited resources available for the costly DAA treatment, implementation of a response-guided treatment (RGT) model to individualize length of DAA therapy in a prospective setting could result in substantial cost saving on HCV drug expenditure in addition to improving patients' compliance to treatment. Furthermore, if adopted at a larger scale, incorporation of such model into clinical practice may enable expansion of access to DAA therapy for patients who are currently not included in the various treatment programs, especially in resource-limited countries.
- Conditions
- Hepatitis C
- Being tested
- Direct acting anti-viral agents
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct acting anti-viral agentsDrug
Also called Treatment
Standard of care for Hepatitis C treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | All subjects will receive a standard of care treatment- Direct acting anti-viral agents Drugs Receives: Drug: Direct acting anti-viral agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sustained virological response (SVR)
Sustained virological response (SVR), defined as an HCV RNA level of less than 10 IU/mL and measured by the Cepheid GeneXpert essay.
Measured: at 12 weeks after the end of treatment in all patients who received at least 4 weeks of therapy with any of the 5 optional drug regimens.
The percentage of patients in whom duration of treatment with DAA can be shortened to less than 12 weeks.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start25 Feb 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University, Harel Dahari, PhD, mathematical modeling support
- Responsible party
- Principal investigator, Ohad Etzion, Soroka University Medical Center
- Investigators
- Ohad Etzion, MD, Principal investigator, Soroka UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603327
- Sponsor's protocol ID
- 0285-17-SOR
- Status last verified
- Feb 2021
- First submitted
- 13 Jun 2018
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Etzion O, Dahari H, Yardeni D, Issachar A, Nevo-Shor A, Cohen-Naftaly M, Ashur Y, Uprichard SL, Arbib OS, Munteanu D, Braun M, Cotler SJ, Abufreha N, Keren-Naus A, Shemer-Avni Y, Mor O, Murad J, Novack V, Shlomai A. Response guided therapy for reducing duration of direct acting antivirals in chronic hepatitis C infected patients: a Pilot study. Sci Rep. 2020 Oct 20;10(1):17820. doi: 10.1038/s41598-020-74568-x.
PubMed 33082372
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Response Guided Treatment With Direct Acting Anti-Viral Medications for Chronic HCV Infection - A Pilot Study
- ClinicalTrials.gov ID
- NCT03603327
- Acronym / sponsor ID
- 0285-17-SOR
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Loyola University, Harel Dahari, PhD, mathematical modeling support
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of direct acting anti-viral agents (DAA) therapy in chronically infected Hepatitis C Virus (HCV) patients using an individualized response guided therapy (RGT) model.
Detailed description
Treatment of HCV infection is directed at achieving sustained virological response (SVR), defined as the continued absence of detectable HCV RNA for 12 or more weeks after completion of therapy Given the limited resources available for the costly DAA treatment, implementation of a response-guided treatment (RGT) model to individualize length of DAA therapy in a prospective setting could result in substantial cost saving on HCV drug expenditure in addition to improving patients' compliance to treatment. Furthermore, if adopted at a larger scale, incorporation of such model into clinical practice may enable expansion of access to DAA therapy for patients who are currently not included in the various treatment programs, especially in resource-limited countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Drug: Direct acting anti-viral agentsAll subjects will receive a standard of care treatment- Direct acting anti-viral agents Drugs |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Signed informed consent
- Clalit insured patients
- Female and male over the age of 18
- Capacity to provide written informed consent
- HCV RNA Viral Load (VL) larger than 105 IU/mL at screening and on at least one other occasion 6 months or more prior to the most recent HCV RNA test result.
Key exclusion criteria (13 listed)
- Clinical, serologic or histopathological evidence supporting the presence of chronic liver disease other than HCV (Including but not limited to: HBV, HDV or HIV coinfection, non-alcoholic steatohepatitis, alcoholic liver disease, Wilson's disease, A1AT deficiency and Celiac disease). Workup performed within 6 months of recruitment will be considered sufficient to exclude the above-mentioned conditions (except for A1AT deficiency and Wilson's disease for which exclusion at any time point qualifies).
- Current or past history of any of the following:
- Any prior treatment with a DAA (protease inhibitors, NS5A inhibitors, NS5B polymerase inhibitors/non-nucleoside polymerase inhibitors)
- Use of anti-viral medications within 30 days of screening.
- Chronic use of systemically administered immunosuppressive/immune- modulating medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct acting anti-viral agentsAlso: TreatmentStandard of care for Hepatitis C treatment | Drug | Treatment |
Primary outcome
Rate of sustained virological response (SVR)
Time frame: at 12 weeks after the end of treatment in all patients who received at least 4 weeks of therapy with any of the 5 optional drug regimens.
Sustained virological response (SVR), defined as an HCV RNA level of less than 10 IU/mL and measured by the Cepheid GeneXpert essay.
The percentage of patients in whom duration of treatment with DAA can be shortened to less than 12 weeks.
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 33082372Etzion O, Dahari H, Yardeni D, Issachar A, Nevo-Shor A, Cohen-Naftaly M, Ashur Y, Uprichard SL, Arbib OS, Munteanu D, Braun M, Cotler SJ, Abufreha N, Keren-Naus A, Shemer-Avni Y, Mor O, Murad J, Novack V, Shlomai A. Response guided therapy for reducing duration of direct acting antivirals in chronic hepatitis C infected patients: a Pilot study. Sci Rep. 2020 Oct 20;10(1):17820. doi: 10.1038/s41598-020-74568-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ohad Etzion, MD principal investigator
Soroka UMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct acting anti-viral agents in people with Hepatitis C, run by Soroka University Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of sustained virological response (SVR) (time frame: at 12 weeks after the end of treatment in all patients who received at least 4 weeks of therapy with any of the 5 optional drug regimens.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03603327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.